Eric W. Stroup

#WorldDenseBreastDay is September 25, 2024. My wife is a mammographer who performs on average 25-30 patient #mammograms a day. She sees her share #Densebreasts! Myself, having worked for a couple #womenshealth /breast health #medtech companies in my career, dense breast are a risk factor for #breastcancer and can make it harder for radiologist to detect breast cancer on mammograms. Dense breasts refer to breast tissue that has less fat and more glandular or fibrous tissue, making it appear white on a mammogram. Now dense breasts can be normal, but it is associated with a higher risk of breast cancer and can make it more challenging to detect abnormalities on a mammogram. This year’s World Breast Density Day is significant because it follows the FDA’s recent decision to implement a national “dense breast” reporting requirement, set to go into effect in September 2024, as my friend Darrin Dodge pointed out. This regulation is a game-changer in the world #breasthealth. It mandates that physicians inform women if they have dense breast tissue. Thank you for sharing Darrin! #breastcare #breastscreening #breastcancerawareness

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International Conference on Aluminum Alloys June 23-27, 2024 at the Georgia Tech Global Learning Center. ICAA is the renowned series of International Conferences on Aluminum Alloys. It provides a forum for scientists and experts from universities and industrial and other research laboratories to present and discuss new developments in the science and technology of aluminum alloys, on their production, processing and physical metallurgy of semis and their broad applications. It gives a unique view on the actual R&D developments and scientific progress and offer a global perspective on the current focus of research and development with in-depth understanding of conventional and advanced aluminum alloys, processes, products and applications, also supporting computational modeling across entire processes. The ICAA conferences specifically promote interaction and contacts between scientists and industrial producers and users of Aluminum. Learn more at icaa19.org.

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Clinical Innovators | Ever wonder what it takes to get a medical device to market? Below I share some insights on the cost and time of development and how The Zewski Report can help simplify the journey. Check it out!

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Great opportunity to visit North America Manufacturing Excellence Summit (NAMES24) in Fort Worth, Texas and meet manufacturing & supply chain executives. Interesting to see other manufacturers tactics and strategies, emerging artificial intelligence or how they find, train, and retain the people they need to succeed in New Normal environment. Please see just few takeaways:  - 88% leaders expect an even faster rate of change in 2024 - 75% says retaining talents is a top challenge - Leaders rank leadership as the No.1 driver when transformation successful, but only No.10 when transformation underperforms. Workers rank leadership No.1 regardless! #hollisterlietuva #wearehollister #NAMES24

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Transitions - Life is full of transitions. Maybe it’s a new role or new job. Maybe it’s a big move. It could be having a child or them growing up and leaving the house. What we don’t realize is we often underestimate the impact these transitions have on us. Transitions require more of us physically, mentally, and emotionally. During these periods we need to build in extra time for rest and margin. We also need to give extra attention to how we are managing our emotions. Big changes can be tough, so make sure you give yourself a little more grace as well. If you have multiple significant transitions happening at the same time, take extra time to reflect and be self aware of how it’s impacting you. Transitions bring great opportunities, so don’t be afraid of them, but make sure you give them the respect they deserve.

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The FDA has a problem -- FDA stands for the Food and Drug Administration. The problem is that the agency's name is limited "foods" and "drugs", and that name fails to convey to the public 1) the broad variety of products within the FDA's regulatory authority, and 2) the many activities that the agency is taking to fulfill it's mission to promote and protect the public health. This video is a step in the right direction at creating public awareness of the agency!

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Have you renewed your 𝗦𝗺𝗮𝗹𝗹 𝗕𝘂𝘀𝗶𝗻𝗲𝘀𝘀 𝗗𝗲𝘀𝗶𝗴𝗻𝗮𝘁𝗶𝗼𝗻 yet? 😲 If not, then 𝘺𝘰𝘶'𝘳𝘦 𝘭𝘢𝘵𝘦, 𝘺𝘰𝘶'𝘳𝘦 𝘭𝘢𝘵𝘦 𝘧𝘰𝘳 𝘢 𝘝𝘌𝘙𝘠 𝘪𝘮𝘱𝘰𝘳𝘵𝘢𝘯𝘵 𝘥𝘢𝘵𝘦. 𝘕𝘰 𝘵𝘪𝘮𝘦 𝘵𝘰 𝘴𝘢𝘺 𝘩𝘦𝘭𝘭𝘰, 𝘨𝘰𝘰𝘥𝘣𝘺𝘦, 𝘺𝘰𝘶'𝘳𝘦 𝘭𝘢𝘵𝘦 𝘺𝘰𝘶'𝘳𝘦 𝘭𝘢𝘵𝘦 𝘺𝘰𝘶'𝘳𝘦 𝘭𝘢𝘵𝘦. The FDA's new fiscal year starts October 1st, after which The Red Queen will stop accepting applications for renewal. And THAT means you'll have to pay full price for any FY2025 submissions. The Small Business Designation can save startups and other small companies up to $16K per submission - more if you're considering a de novo or PMA. Sad to say that 𝘰𝘯𝘭𝘺 𝘢 𝘧𝘦𝘸 𝘧𝘪𝘯𝘥 𝘵𝘩𝘦 𝘸𝘢𝘺, 𝘴𝘰𝘮𝘦 𝘥𝘰𝘯’𝘵 𝘳𝘦𝘤𝘰𝘨𝘯𝘪𝘻𝘦 𝘪𝘵 𝘸𝘩𝘦𝘯 𝘵𝘩𝘦𝘺 𝘥𝘰 – 𝘴𝘰𝘮𝘦… 𝘥𝘰𝘯’𝘵 𝘦𝘷𝘦𝘳 𝘸𝘢𝘯𝘵 𝘵𝘰. Even if you were granted an SBD number earlier this year, you still have to reapply because 𝗲𝘃𝗲𝗿𝘆 𝗦𝗕𝗗 𝗴𝗿𝗮𝗻𝘁𝗲𝗱 𝗶𝗻 𝗮 𝗴𝗶𝘃𝗲𝗻 𝗳𝗶𝘀𝗰𝗮𝗹 𝘆𝗲𝗮𝗿 𝗲𝘅𝗽𝗶𝗿𝗲𝘀 𝗦𝗲𝗽𝘁𝗲𝗺𝗯𝗲𝗿 𝟯𝟬𝘁𝗵.    Every SBD, every year, no matter what, so 𝘭𝘦𝘵 𝘺𝘰𝘶𝘳 𝘯𝘦𝘦𝘥 𝘨𝘶𝘪𝘥𝘦 𝘺𝘰𝘶𝘳 𝘣𝘦𝘩𝘢𝘷𝘪𝘰𝘳. Applying for your SBD is not difficult, but it does require gathering a LOT of tax records and other business accounting documentation. 𝘉𝘦𝘨𝘪𝘯 𝘢𝘵 𝘵𝘩𝘦 𝘣𝘦𝘨𝘪𝘯𝘯𝘪𝘯𝘨, 𝘢𝘯𝘥 𝘨𝘰 𝘰𝘯 𝘵𝘪𝘭𝘭 𝘺𝘰𝘶 𝘤𝘰𝘮𝘦 𝘵𝘰 𝘵𝘩𝘦 𝘦𝘯𝘥: 𝘵𝘩𝘦𝘯 𝘴𝘵𝘰𝘱. You may wish you 𝘩𝘢𝘥𝘯’𝘵 𝘨𝘰𝘯𝘦 𝘥𝘰𝘸𝘯 𝘵𝘩𝘢𝘵 𝘳𝘢𝘣𝘣𝘪𝘵-𝘩𝘰𝘭𝘦—𝘢𝘯𝘥 𝘺𝘦𝘵—𝘢𝘯𝘥 𝘺𝘦𝘵—𝘪𝘵’𝘴 𝘳𝘢𝘵𝘩𝘦𝘳 𝘤𝘶𝘳𝘪𝘰𝘶𝘴, 𝘺𝘰𝘶 𝘬𝘯𝘰𝘸, 𝘵𝘩𝘪𝘴 𝘴𝘰𝘳𝘵 𝘰𝘧 𝘭𝘪𝘧𝘦! You'll also need to create a User Fee account with the FDA, and download our FREE guide - How to Obtain a Small Business Designation (SBD) with the FDA - which will walk you through the process step by step: https://lnkd.in/dBazjQe3 If you prefer to have our team of experts walk you through it, give us a shout: https://leanraqa.com/time Apologies to the great Lewis Carrol, but so many of these quotes were applicable, I couldn't resist. 😁 #medicaldevices #regulatoryaffairs #compliance #FDA #qualitymanagement #medtech #biotech #startup #submissions #510k

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Season 7 of the Reliability Leader Podcast is here! In today’s episode, Arash Samimi, PhD and I talk about how to make safe medical devices and how do we make sure these devices work well and safely? Listen to the full episode here: https://lnkd.in/ed5CyesS #reliabilityleader #podcast #medicaldevices

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Usability engineering is where technology meets humanity and if they don’t meet to the likes of humanity, it renders the technology obsolete regardless of its innovation.

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As we enter flu season, the number of respiratory infections increases, and so does the pressure on labs to deliver timely and accurate results. Check out this recent LabLeaders article to find out how to manage this demand! http://spkl.io/6044fJx5a

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“She/He in under construction. Thank you for your patience!” “Her/His current situation is not their final destination! “ In today's competitive business landscape, experience is often prioritized over potential. But what if we looked beyond the resume and considered the untapped potential of "inexperienced" talent? By embracing the power of potential, we can unlock innovation, fresh ideas, and transformative growth within our businesses. Let's challenge the traditional approach to hiring and give the next generation of talent the opportunity to shine. #potentialoverexperience #futureleaders #innovation #growthmindset

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Lisa Earnhardt — the leader of Abbott's #meddevice business — is the most powerful woman in #medtech — and also one of its most powerful executives with an #engineering background. “Engineering is all about problem-solving, and it taught me a methodical way to think about problem-solving. In medtech, we’re solving some of the most challenging problems we’re faced with in terms of #healthcare, and we’re doing it through technology.” Go to Medical Design & Outsourcing to read more of the insights that Lisa Earnhardt shared with Managing Editor Jim Hammerand for our upcoming #WomenInMedtech issue.

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Check out this https://beudamed.com/ created by OpenRegulatory. It is so simple to use in comparison to EUDAMED.

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The World Watches the U.S. Election – Does It Really Matter Who Wins? Today’s U.S. election goes far beyond American borders. The results will drive decisions that impact global economies, reshape alliances, and set the course on urgent issues like healthcare, technology, and climate action. For those of us in sectors like medical devices and healthcare, U.S. policies on regulation, trade, and innovation could mean new opportunities—or new hurdles. As someone leading international teams and navigating complex markets, I know that shifts in U.S. policy can affect our strategies, our growth potential, and even our daily operations. But here’s the real question: does it actually matter who wins? Every election, we hear promises of change, of radical shifts in direction. And yet, somehow, the wheel keeps spinning much the same way. Will one candidate truly set a new course for the world—or are we in for more of the same, dressed up in different colors? Only time will tell us. Regardless of the outcome, my hope is that the next President’s vision will go beyond America and contribute to creating a more just and fair world for everyone. Here’s to real change that benefits us all. Am I a dreamer? Probably. But let me hold on to my hopes. Good luck America, good luck world!

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All Quality Professionals are leaders and should be developed as such. Very few quality professionals are merely along for the ride. On almost every journey, they are either navigating or driving. They provide navigational expertise to development teams by ensuring processes are adhered to, post-market surveillance information is incorporated, and they keep an eye out for compliance gaps leading up to design reviews/stage gates. During continuous improvement and CAPA activities they are driving the initiative by vetting evidence to support the problem statement, checking the viability of planned actions and measuring success towards the goal. During audits and inspections, they drive successful outcomes throughout the event by managing preparation, execution, close-out, and follow-up activities. In these scenarios (and many more), they must feel competent, confident and empowered to speak up and show the way. They need to know the requirements, be willing to provide direction, and have your support. Things to consider: Are your quality professionals ready, willing, and able to be leaders? Have you clearly set these expectations? Are you providing them with what they need to meet these expectations? Click the link for recommended resources... #quality #qualityleadership #professionaldevelopment

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This week the FDA published new draft guidance regarding testing requirements for pulse oximetry devices. At Nonin, we understand the impact of high-quality, accurate oximetry and we are pleased to see the FDA progressing this important issue. I am proud to be a part of the Nonin team, where we work hard every day to provide our patients and caregivers with accurate and high-quality pulse oximeters. https://lnkd.in/gvEjkftw

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Exciting news! As of today, the new FDA mandate requiring mammography facilities to inform patients and their referring physicians about their breast density goes into effect. This is a major leap forward in the fight against #breastcancer. With 70% of all breast cancers occur in women with dense breasts, this mandate highlights the crucial role of supplemental imaging options like Invenia™ ABUS 2.0. Discover how Invenia ABUS 2.0’s patient-friendly and non-invasive technology can enhance the breast cancer journey for your patients with dense breasts and detect #mammography occult breast cancer as early as possible. #BreastHealth #DenseBreasts #3DABUS #BreastUltrasound #Ultrasound

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Big news in the HTM sector: Would love to hear your thoughts! https://lnkd.in/e-6eHw-U Also, who would like to be a guest on my podcast to discuss this? #IamHTM

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